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Regulatory Operations Sr. Publisher

8 hours ago

Parsippany, New Jersey, United States Melinta Therapeutics Llc Full time

Why CorMedix Therapeutics? 

If you are interested in joining an entrepreneurial team, focused on bringing life-saving therapies to market for critical unmet medical needs, consider applying for a role at CorMedix Therapeutics.  The culture at CorMedix Therapeutics is patient-centered where we feel a sense of urgency to solve some of the most pressing issues in hospital-based healthcare.

CorMedix Therapeutics's greatest asset is our people. We have a deeply experienced team and continue to bring on some of the brightest talent that can problem solve and execute with high-precision. We are passionate about the work we do and how we do it. We believe in building highly engaged teams that exude integrity, open communication, and innovation. We believe in fostering each employee to reach their highest potential by offering an inclusive environment, opportunities to challenge yourself and grow, and a community of purpose.  We expect that everyone here brings their best selves to work and together, our singular efforts culminate into profound and meaningful breakthroughs.

Company Description: 

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. CorMedix is commercializing DefenCath (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN (minocycline), REZZAYO (rezafungin), VABOMERE (meropenem and vaborbactam), ORBACTIV (oritavancin), BAXDELA (delafloxacin), and KIMYRSA (oritavancin), as well as TOPROL-XL (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric patient populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations.  REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q For more information visit:  or 

POSITION: 

The Regulatory Operations Sr. Publisher collaborates closely with counterparts in Regulatory Affairs/Cross-functional SMEs and is responsible for managing submission timelines, ensuring submission readiness, and strengthening operational excellence across the organization, including maintenance of eDMS (Electronic Document Management Systems) documents.

Primary Responsibilities:

  • Responsible for the creation, assembly, and publishing of both major and routine electronic submissions, including NDAs, INDs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, AdPromo, etc.
  • Ensure that metadata is correctly applied so that documentation is retrievable and searchable within the company (eDMS) and engage in life cycle management of submission documents to ensure document integrity in eDMS and publishing tool
  • Format Microsoft Word documents using content templates or Microsoft Word styles consistently to prepare for electronic submission publishing
  • Publish and verify documents meet all applicable regulatory submission standards according to internal policies and current Health Authority/ICH (International Conference on Harmonisation) standards/specifications, such as creating bookmarks, internal/external hyperlinks, etc.
  • Perform quality control reviews and follow procedures to identify, document, and remediate findings
  • Manage document management tasks including file transfer, storage, tracking, and archival services.
  • Populate and maintain Reg Ops Submission Calendar
  • Archive correspondence and submissions to/from Health Authorities into eDMS
  • Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA/other Health Authority
  • Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate
  • Other functional duties as requested by management

Qualifications

  • Knowledge, understanding, and experience with Veeva VAULT RIM authoring workflows, document metadata, naming conventions, Veeva submission publishing and Submission Archive
  • Knowledge and understanding of global regulatory submission formats, industry standards, and guidelines, software validation concepts, and publishing best practices
  • Thorough understanding of formatting MS Word documents and authoring templates/tools (StartingPoint templates, etc.)
  • Proficient in Microsoft Windows environment including, but not limited to: Microsoft Office Products, Adobe Acrobat and plug-ins; Microsoft 365 document management systems; publishing product lines. Experience with electronic IND and NDA publishing software  
  • Thorough understanding of the eCTD structure as well as FDA and ICH specifications for eCTD submissions
  • Minimum of 5-7 years pharmaceutical industry experience. End-to-end submission publishing and document management experience (Veeva RIM Vault/Vault Publishing experience is a MUST) required with minimum of 5-7 years using publishing software. May have experience with, but not limited to: Veeva Vault (RIM, eTMF, Promomats – etc) Veeva Publishing, Lorenz docuBridge, Lorenz eValidator, Insight Manager /Publisher Insight Validator, ISI Toolbox, ESG gateway
  • Must be able to work independently and be dedicated to quality and meeting timelines.
  • Excellent verbal and written communication skills coupled with a great attitude/mindset/ability to work in and support collaborative team environment
  • Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects
  • Openness towards continual learning and improvement

Position Type

  • Full Time - Exempt Position

Travel

  • Fully Remote position 
  • Travel requirement as needed, approximately 10%

EEO Statement:  

CorMedix Therapeutics is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix Therapeutics does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law.